Cranberry Tablet Stretches Definition Of A Medical Device

Let me just check the diary? No, it’s not April 1st

In life there are many occasions when things don’t fit into neatly defined pigeon holes. Having said that, we’re more than a little surprised to see that the lack of an obvious classification for a therapeutic cranberry capsule has resulted in it finding its way into Europe as a Class IIa medical device.

Dutch company, the snappily named “Medical Brands”,┬áhas obtained a Class IIa Medical Device Status for its patented Cranberry-Active capsule, making it the first and only cranberry-based product in Europe to have a “proven” medical claim.

But how come it’s not a food, or a drug? And how come it’s being sold over the counter?

Well, the plain fact is that Medical Brands, together with its US partner, Decas Botanical Synergies has spent a lot of time an money navigating its way through the regulatory jungle and whether they’ve found a loophole or not is a moot point, because a German notified body has apparently “said yes”(excuse the Del Monte reference).

So what we have is something which is a natural product which does not have a pharmacological effect, yet has been demonstrated to be effective in treatment of urinary tract infections, so isn’t strictly a food either, probably because of its presentation as a capsule, although why this distinguishes it from hundreds of products found in your local Holland and Barrett (or equivalent health store) is uncertain.

Company comments

“Bladder- and urinary tract infections (UTIs) are a serious health problem, affecting millions of people each year. Today, antibiotics are the traditional treatment for UTIs but there is a growing global push towards other solutions as resistance to antibiotics continues to rise. Our Cranberry-Active capsules marketing authorization is the culmination of years of planning, development and clinical investigation,” says Maikel Hendriks, president of Medical Brands.

We remain bemused, but the fact is we’re covering the story so it must be a medical device.

Source: Medical Brands